PSMA-guided surgery and immune cell study in prostate cancer that has reached lymph nodes
Studies immune cells in tumor tissue during PSMA-guided surgery in 12 men with prostate cancer.
Plain-language title generated from the registry record
Registry title: PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer
Key facts
- Where
- Milan, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread to pelvic lymph nodes on a PSMA PET scan and who are planned for robot-assisted prostate removal surgery.
- Age
- 18 to 85 years
- Sex
- Men only
- Disease stage
- Biopsy-proven prostate cancer with positive lymph nodes on PSMA PET (miN+), without bone or organ metastases (M1b-c).
- Earlier treatment
- Cannot have had hormone therapy before surgery, chemotherapy, brachytherapy or external-beam radiotherapy. Surgery planned: robot-assisted radical prostatectomy with extended pelvic lymph-node dissection.
- Biomarker or test result
- Positive lymph nodes on staging PSMA PET.
Main reasons for not taking part
- Bone or organ metastases (M1b-c) on imaging before surgery
- Life expectancy under 12 months
- Congestive heart failure
- Allergy likely to be made worse by the study drugs or the 68Ga-PSMA tracer
- Experimental drug within 30 days before the tracer
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07879820, who can take part
Where in Italy
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Niguarda Hospital
- Trial code
- NCT07879820
- Record updated
- 19 October 2026
- Original description
TACTIC-P is a single-center, prospective, single-arm study in 12 men with biopsy-proven prostate cancer and pelvic lymph-node uptake on preoperative PSMA PET, without bone or visceral metastases, who are scheduled for robot-assisted radical prostatectomy and extended pelvic lymph-node dissection. On the day of surgery, participants receive intravenous gallium-68 PSMA-11 followed by PET/CT and PSMA-radioguided surgery using a drop-in gamma probe. Resected prostate tumor, metastatic lymph-node tissue, and matched blood samples are used for high-dimensional immune profiling. The main goal is to determine whether functional pathogen-specific bystander tissue-resident T cells can be identified and quantitatively characterized in the primary tumor and/or metastatic lymph nodes. The study also evaluates immune features relevant to future personalized immunotherapy, the ability of PSMA-radioguided surgery to detect pathologically positive lymph nodes, and perioperative safety through 12 weeks after surgery.Read full original descriptionShow less
Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
TACTIC-P is a single-center, prospective, single-arm study in 12 men with biopsy-proven prostate cancer and pelvic lymph-node uptake on preoperative PSMA PET, without bone or visceral metastases, who are scheduled for robot-assisted radical prostatectomy and extended pelvic lymph-node dissection. On the day of surgery, participants receive intravenous gallium-68 PSMA-11 followed by PET/CT and PSMA-radioguided surgery using a drop-in gamma probe. Resected prostate tumor, metastatic lymph-node tissue, and matched blood samples are used for high-dimensional immune profiling. The main goal is to determine whether functional pathogen-specific bystander tissue-resident T cells can be identified and quantitatively characterized in the primary tumor and/or metastatic lymph nodes. The study also evaluates immune features relevant to future personalized immunotherapy, the ability of PSMA-radioguided surgery to detect pathologically positive lymph nodes, and perioperative safety through 12 weeks after surgery.
Inclusion: Male participants; Age 18 to 85 years; Biopsy-proven prostate cancer with positive lymph nodes on staging PSMA PET (miN+); Planned robot-assisted radical prostatectomy with extended pelvic lymph-node dissection; Able to understand and willing to sign written informed consent.
Exclusion: Neoadjuvant hormonal therapy before surgery; Previous chemotherapy; Previous brachytherapy or external-beam radiotherapy; Experimental drug within 30 days before radiotracer administration or within 5 half-lives of that experimental drug; Bone or visceral metastatic disease (M1b-c) on preoperative imaging; Congestive heart failure; Any other significant disease/disorder that, in the investigator's opinion, may increase risk, influence study results, or impair participation; History of allergic disease/reactions likely to be exacerbated by study IMPs or radiotracer components (68Ga-PSMA); Inability to complete imaging examinations according to the protocol; Life expectancy <12 months.